Device Survival Probability
ADSR01_ADSR03_ADSR06_SURV
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | 10 yr | 11 yr | at 135.0 mo | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | |||||||||
| % |  |
99.9 | 99.7 | 99.5 | 99.0 | 98.3 | 97.1 | 94.6 | 88.7 | 72.2 | 51.2 | 29.0 | 21.5 | |||||||||
| # | 72028 | 62944 | 55093 | 48012 | 41196 | 34864 | 28921 | 22170 | 13793 | 5968 | 1154 | 325 |
- Including Normal Battery Depletion – This curve includes devices that have reached at least 80% of expected longevity. This curve is most representative of clinical performance and how long the device will last.
- Excluding Normal Battery Depletion – This is the malfunction free survival curve.
Customer Communications For This Model
- There are no communications for this model.
Product Characteristics
| Generator Type | IPG |
|---|---|
| NBD Code | SSIR |
| Max. Delivered Energy | N/A |
| Connector Style | 5/6mm UNI |
|---|---|
| Serial Number Prefix | NWN, PWN |
| Mass | 22.5 g |
| Volume | 11.0 cc |
| Waveform | N/A |
| X-Ray ID | PWB, NWN |
Estimated Longevity
| Amplitude Setting | 500 Lead Ω | 1000 Lead Ω |
|---|---|---|
| Low 2.5 V (A, RV) | 7.4 | 8.9* | 7.9 | 9.7* |
| Nominal 3.5 V (A, RV) | 6.5 | 7.7* | 7.5 | 9.1* |
| High 5.0 V (A, RV) | 5.1 | 5.9* | 6.3 | 7.4* |
*The second longevity numbers provided apply to the N-series Adapta ADSR06 product. The N-series products have increased longevity because of improved electronic circuitry. Click on "Other Articles" for more information on the N-series longevity. Longevity estimates based on the following device usage. Pace/Sense Mode VVI ; Right Ventricle Pulse Width 0.4 ms; Lower Pace Rate 60 bpm; Right Ventricle Percent Paced 100 %; EGM Prestorage ON ; Upper Sensing Rate 130 ppm; EGM Prestorage ON Time 1 ; Hide this content
Distribution Data
| US Market Release | 2006-07-17 |
|---|---|
| CE Approval Date | 2005-09-20 |
| Registered USA Implants | 2901 |
| Estimated Active USA Implants | 605 |
| Normal Battery Depletions | 268 |
| US Market Release | 2006-07-17 |
|---|---|
| CE Approval Date | 2005-09-20 |
| Estimated WW Distribution | 10961 |
| Normal Battery Depletions | 347 |
Malfunctions (USA)
| Therapy Function Not Compromised | 2 |
|---|---|
| Electrical Component | 2 |
| Therapy Function Compromised | 0 |
Malfunctions (WW)
| Therapy Function Not Compromised | 2 |
|---|---|
| Electrical Component | 2 |
| Therapy Function Compromised | 0 |
EOS Indication
From the point that the ERI is set, the pacemaker will operate at ERI conditions for approximately three months for typical pacemaker configurations during the normal operating life.
Recommended Replacement (RRT)
Telemetry indication. Rate and mode change to 65 ppm and VVI respectively (VOO/65 with magnet).
Data as of April 30, 2024